MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG TELETOM; BOOM

Catalog Number TEL00000001

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that a monitor fell off the shape arm in operating room 7.In the process of trying to catch the falling monitor, a nurse was reported to have injured her shoulder and required treatment and missed work.It is likely that a lack of maintenance occurred and over time the screws holding the shape arm up backed out, leading to the falling of the shape arm.The shape arm was removed by the customer and the stryker field service technician(sfst) was unable to locate the removed shape arm while onsite.If further information is found following the investigation, a supplemental will be filed.Device not returned and unable to find at customer site.

Event Description

It was reported that a monitor fell off the shape arm in operating room 7.In the process of trying to catch the falling monitor in operating room 7, a nurse was reported to have injured her shoulder and required treatment and missed work.

Event Description

It was reported that a monitor fell off the shape arm in or 7.In the process of trying to catch the falling monitor in or 7, a nurse was reported to have injured her shoulder and required treatment and missed work.

Manufacturer Narrative

During the investigation stryker found the serial number to be (b)(4).It was also confirmed there was no serious injury to the nurse.

• Brand Name: TELETOM
• Type of Device: BOOM
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• MDR Report Key: 7660822
• MDR Text Key: 113159369
• Report Number: 0008010153-2018-00007
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TEL00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other